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dc.date.accessioned2020-04-29T09:26:01Z
dc.date.available2020-04-29T09:26:01Z
dc.date.created2018-07-13T10:01:03Z
dc.date.issued2018
dc.identifier.citationLupattelli, Angela Spigset, Olav Nordeng, Hedvig Marie Egeland . Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance. International Journal of Clinical Pharmacy. 2018, 40(4), 783-786
dc.identifier.urihttp://hdl.handle.net/10852/74956
dc.description.abstractThe growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.
dc.languageEN
dc.titleLearning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance
dc.typeJournal article
dc.creator.authorLupattelli, Angela
dc.creator.authorSpigset, Olav
dc.creator.authorNordeng, Hedvig Marie Egeland
cristin.unitcode185,15,23,10
cristin.unitnameGalenisk farmasi og samfunnsfarmasi
cristin.ispublishedtrue
cristin.fulltextpostprint
cristin.qualitycode1
dc.identifier.cristin1597056
dc.identifier.bibliographiccitationinfo:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=International Journal of Clinical Pharmacy&rft.volume=40&rft.spage=783&rft.date=2018
dc.identifier.jtitleInternational Journal of Clinical Pharmacy
dc.identifier.volume40
dc.identifier.issue4
dc.identifier.startpage783
dc.identifier.endpage786
dc.identifier.doihttps://doi.org/10.1007/s11096-018-0672-2
dc.identifier.urnURN:NBN:no-78069
dc.type.documentTidsskriftartikkel
dc.type.peerreviewedPeer reviewed
dc.source.issn2210-7703
dc.identifier.fulltextFulltext https://www.duo.uio.no/bitstream/handle/10852/74956/2/Learning%2Bthe%2Beffects%2Bof%2Bpsychotropic%2Bdrugs%2Bduring%2Bpregnancy%2Busing%2Breal-world%2Bsafety.pdf
dc.type.versionAcceptedVersion


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